Method and device for suture isolation

ABSTRACT

A method and device provides features for the temporary “parking” of sutures with respect to a cannula. In the preferred embodiments the features are slots that maintain tension on, and orientation of, sutures placed therein. The slots or features may be integral with the cannula or part of a separate device which may be removably affixed to the external portion of a cannula. The invention eliminates the multiple steps inherent in current suture management techniques for arthroscopic procedures, particularly rotator cuff repair and assists in tensioning/advancement of tissue into its repair site.

REFERENCE TO RELATED APPLICATION

This application claims priority from U.S. Provisional PatentApplication Ser. No. 60/484,243, filed Jul. 2, 2003, the entire contentof which is incorporated herein by reference.

FIELD OF THE INVENTION

The disclosed invention relates to arthroscopic surgery, and moreparticularly, to the control of sutures to prevent tangling duringarthroscopic procedures including rotator cuff repair, labral repair andother soft tissue apposition.

BACKGROUND OF THE INVENTION

The advantages of arthroscopic surgery are significant, however, theprocedure has been technically demanding, particularly with respect torotator cuff repair. The introduction of second-generation anchors withimproved holding power and larger eyes which allow sutures to slideeasily through them, and clear cannulas which improve visualization, hasmade the procedure easier. Until recently, however, passing suturethrough the cuff has been a challenging, multi-step process beyond theskill (or patience level) of many surgeons. This is especially true forsurgeons who only infrequently do rotator cuff repairs.

In 2001 in the state of New York, 9,207 cuff repairs were performed by859 surgeons. During this time period, 90 percent of the New Yorkdoctors who performed rotator cuff repairs performed 24 or fewer cuffrepairs each, an average of less than one every two weeks. Theinfrequency with which these doctors perform the procedure generallyprevents them from developing the skills necessary to perform theprocedure arthroscopically. The recent introduction to the market ofinstruments which are able to pass braided suture without the use of ashuttle (a device which is first passed through the cuff, and is thenused to pull the suture through the cuff) has removed much of thedifficulty. The ExpresSew™ by Surgical Solutions, LLC (Valencia, Calif.)is able to directly pass braided suture through a cuff. The NeedlePunch™ by Arthrex Incorporated (Naples, Fla.) is able to grasp the cuff,pass braided suture through the cuff, and bring the suture out throughthe cannula used for access (the working cannula).

While the problem of passing a suture through a cuff arthroscopicallyhas been largely eliminated, suture management has become critical tothe technical success of the surgery. Indeed, tangled sutures canterminate an arthroscopic procedure. This problem is compounded by thefact that many anchors now are loaded with two sutures so as to createtwo vertical stitches which can be slightly separated so as todistribute the load over a greater area of the tendon. This improves thestrength of the repair, but at the same time gives the surgeon foursuture “legs” with which to deal.

Arthroscopic rotator cuff repairs are performed in a space which isfilled with pressurized liquid, generally normal saline, the surgeonworking through various small incisions or portals. Pressurization ofthe joint and leakage of liquid from the joint is controlled by cannulaewhich are inserted into the portals, the cannulae having seals throughwhich instruments and sutures may be passed.

Common suture management techniques call for removal of sutures from theworking cannula in order to avoid tangles. The sutures are thenretrieved one at a time as needed. Some advocate making extra puncturesfor the sole purpose of temporarily storing sutures to avoid tangles.Others recommend retrieving one suture through the mid-glenoid workingcannula, and retrieving the other limbs through the anterior superiorcannula, after which the cannula is removed and reinserted leaving thesutures through the portal outside the cannula. Transporting suturesfrom one cannula to another or to alternative portals can occupy largeblocks of time during a given operation. Also, removing and reinsertinga cannula may increase trauma to local tissues. There is a need for amore efficient suture management system, minimizing the multiple extrasteps inherent in the currently recommended techniques and theirassociated increased trauma.

Performing an arthroscopic rotator cuff repair is a multi-step process.The bone bed is prepared using a high-speed buf, adjacent to thearticular surface of the humeral head. Anchors are placed in the bonebed, each anchor generally loaded with two strands of suture so thatfour tails are created. One leg of each suture is passed through thecuff, suitably spaced so as to distribute the load over a greater areaof the tendon. One set of sutures is pulled laterally as tractionsutures to retain tension and position of the cuff during suture knottying of the second set of sutures. Traction suture tension is generallymaintained by an assistant holding onto the suture legs which pass fromthe working cannula. The traction sutures are tied after the first setof sutures. The process of applying traction and tying suture pairs isrepeated until all sutures are tied. There is currently no method forapplying tension to a traction suture which does not require anassistant to hold the suture.

The use of a traction suture also frequently leads to excessive leakingand spraying from the working cannula since the suture under tensionoften distorts the seal through which the suture passes thereby allowingthe flow of liquid.

It is, accordingly, an object of this invention to produce a method forsuture management which prevents tangling of sutures and allowstensioning of a traction suture without manual assistance.

It is also an object of this invention to produce a method fortensioning a traction suture while minimizing fluid leakage from thejoint.

It is also an object of this invention to produce a method fortensioning a traction suture while maintaining fluid pressure within thejoint.

It is also an object of this invention to produce a method for suturemanagement which prevents tangling of sutures but does not requiretransporting of sutures from the working cannula to avoid tangles.

It is also an object of this invention to produce a method for suturemanagement which prevents tangling of sutures and thereby reducesprocedure time and complexity.

It is, accordingly, an object of this invention to produce a device forsuture management which prevents tangling of sutures and allowstensioning of a traction suture without manual assistance.

It is also an object of this invention to produce a device fortensioning a traction suture while minimizing fluid leakage from thejoint.

It is also an object of this invention to produce a device fortensioning a traction suture while maintaining fluid pressure within thejoint.

It is also an object of this invention to produce a device for suturemanagement which prevents tangling of sutures but does not requiretransporting of sutures from the working cannula to avoid tangles.

It is also an object of this invention to produce a device for suturemanagement which prevents tangling of sutures and thereby reducesprocedure time and complexity.

SUMMARY OF THE INVENTION

These and other objects are achieved in the invention herein disclosedwhich is a method and device for management of sutures within theworking cannula through the temporary “parking” of sutures within slotson the exterior portion of the cannula, the slots maintaining tensionon, and orientation of, sutures placed therein. In one embodiment theslots are integral with the cannula. In another the slots are part of aseparate device which may be removably affixed to the external portionof a cannula. In yet another embodiment the cannula with integral slotshas a seal configured to minimize leakage through the seal when sutures,especially traction sutures, are used in the cannula.

Maintaining tension on a given suture and controlling the orientation ofeach suture with respect to its neighbor reduces the likelihood oftangles even when all sutures are contained within the same cannula thatis being used to pass instruments (the working cannula). As each sutureis inserted two tails (or legs) are created. For a rotator cuff repairinvolving the supraspinatus tendon, one limb is below and one on top ofthe tendon. As the sutures are inserted this orientation is easilyrecognized and can be maintained by the disclosed device with slighttension on each suture limb. The tension prevents loops of suture fromforming. Therefore the insertion of additional sutures is collinear withthe existing sutures and tangles do not occur. As the sutures are tieddown, the knots slide smoothly as the limbs' orientations have beenmaintained and the limbs are not crossed.

When a suture pair is to be used as a traction suture, the legs arepulled to achieve the desired displacement of the cuff and the suturestemporarily secured to the suture isolator. The axial force on thecannula due to tension in the traction suture may cause the cannula toadvance into the portal. This can be prevented by affixing a suitableclamp or spacer to the cannula proximal to the portal.

The invention herein disclosed eliminates the multiple steps inherent incurrent suture management techniques for rotator cuff repair. Thisresults in decreased opportunities for errors and significant timesavings for the surgeon. Because the sutures are managed within theworking cannula, removal and reinsertion of cannulas for suture controlwith the associated increased trauma to local tissues, are avoided.

These and other objects and features of the invention will become morefully apparent when the following detailed description is read inconjunction with the accompanying figures and examples.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is plan view of a suture isolator constructed in accordance withthe principles of this invention

FIG. 2 is a proximal axial view of the object of FIG. 1;

FIG. 3 is a side-elevational sectional view of the object of FIG. 1;

FIG. 4 is a plan view of an arthroscopy cannula of the type used withthe invention herein disclosed;

FIG. 5 is a proximal axial view of the object of FIG. 4;

FIG. 6 is a perspective view of the object of FIG. 4;

FIG. 7 a plan view of the object of FIG. 1 assembled to the object ofFIG. 4;

FIG. 8 is a proximal axial view of the objects of FIG. 7;

FIG. 9 is a perspective view of the objects of FIG. 7;

FIG. 10 is a plan view of an alternate embodiment constructed inaccordance with the principles of this invention;

FIG. 11 is a proximal axial view of the object of FIG. 10;

FIG. 12 is a side sectional view of the object of FIG. 10;

FIG. 13 is a perspective view of the object of FIG. 10 assembled to theobject of FIG. 4;

FIG. 14 is a plan view of another alternate embodiment constructed inaccordance with the principles of this invention;

FIG. 15 is a proximal axial view of the object of FIG. 14;

FIG. 16 is a perspective view of the object of FIG. 14;

FIG. 17 is an expanded proximal axial view of the object of FIG. 14showing suture placement in the seal during use;

FIG. 18 is a perspective view of the object of FIG. 14 during use;

FIG. 19 is a proximal axial view of an alternate embodiment;

FIG. 20 is a perspective view of the object of FIG. 19;

FIG. 21 is a proximal axial view of an alternate embodiment;

FIG. 22 is a perspective view of the object of FIG. 21;

FIG. 23 show a top view of the rotator cuff edge;

FIG. 24 shows anchors deployed; and

FIG. 25 shows the rotator cuff edge reduced into its insertion area bytensioning sutures.

DETAILED DESCRIPTION OF THE INVENTION

Referring to FIGS. 1 through 3, suture isolator 1 has a proximal end 2,a distal end 4, outer diameter 6 and length 8. Distal portion 10 has arecess 12 formed therein, recess 12 having a cylindrical portion 14 ofdiameter 16 and a tapered portion 17 in which the diameter increases todiameter 18. Proximal portion 20 has a cylindrical recess 22 of diameter24 formed therein so as to produce proximal rim 26. Proximal rim 26 hasa plurality of slots 28 of depth 30 having a distal portion 32 of width34 and a tapered proximal portion 36. Width 34 of distal portion 32 isless than the thickness of the suture generally used for arthroscopicrotator cuff repair so that suture removably placed in slots 28 is heldsecurely. Isolator 1 is made of a rigid metallic or polymeric material.

Referring to FIGS. 4 through 6, cannula 40 has an elongated tubulardistal portion 42 of diameter 44 and a proximal portion 46 of diameter48, diameter 48 being slightly greater than diameter 16 and slightlyless than diameter 18 of distal circular recess of suture isolator 1(FIGS. 1 through 3). Near proximal end 50 of distal portion 42, inflowtube 52 provides a means for supplying irrigant to the inner lumen ofdistal portion 42. Deformable polymeric seal 54 having a plurality ofslits 55 closely conforms to instruments placed therethrough so asminimize leakage of fluid from the site.

Referring to FIGS. 7 through 9, suture isolator 1 is removably affixedto cannula 40, cylindrical portion 14 of recess 12 of isolator 1 (FIGS.1 through 3) deformably mating to the proximal portion of proximalportion 46 of cannula 40, diameter 48 of portion 46 being slightlylarger than diameter 16 of recess 12 (FIGS. 1 through 3). Mounting ofisolator 1 to cannula 40 is facilitated by tapered portion 17 of recess12.

In another embodiment, shown in FIGS. 10 through 12, suture isolator 60,made from a suitable resilient polymeric material such as neoprene whichdeforms to allow the passage of instruments, has a tubular distalportion 62 having an inner cylindrical diameter 64, and a closed-endproximal portion 66 having a proximal wall 68 wherein is formed opening70. Diameter 64 is somewhat smaller than diameter 48 of proximal portion46 of cannula 40 (FIGS. 4 through 6). Opening 70 has a plurality ofradial slots 72 having a width 74 less than the thickness of the suturegenerally used for arthroscopic rotator cuff repair so that sutureremovably placed in slots 72 is held securely.

The configuration of isolator 60 made from resilient polymeric materialdiffers from that of isolator 1 made from rigid material. Note thatwhereas slots 28 of isolator 60 (FIGS. 1 through 3) are oriented axiallyand positioned in proximal rim 26, slots 72 are oriented radially andpositioned in proximal wall 68. If an suture isolator made of aresilient material is formed like isolator 1 with radial slots in theproximal rim, stretching the isolator so that it mounts to the largerdiameter of the proximal portion of a cannula may cause unacceptablewidening of the slots so that suture placed therein is not securelygrasped.

Referring to FIG. 13, suture isolator 60 is removably mounted to cannula40, distal portion 62 deformably mating to the proximal portion 46 ofcannula 40, diameter 48 of portion 46 (FIGS. 7 through 9) being largerthan diameter 64 of distal portion 62 of isolator 60.

Because of the resilient material of which isolator 60 is formed, theholding power of slots 72 may be insufficient for maintaining tension insome traction sutures. Accordingly, another embodiment (not shown) usesa combination of isolator 1 (FIGS. 1 through 3) and isolator 60,isolator 1 having a distal recess configured to be removably mounted totubular distal portion 62 of isolator 60. Sutures are passed throughslots 72 of isolator 60 and removably affixed to slots 28 of isolator 1,isolator 60 aiding in isolation of the sutures and preventing leakagefrom the seal from spraying from the isolator.

In yet another embodiment shown in FIGS. 14 through 16, the sutureretaining slots are integral to the cannula. Cannula 80 has an elongatedtubular distal portion 82 of diameter 84 and a proximal portion 86 ofdiameter 88. Near proximal end 90 of distal portion 82, inflow tube 92provides a means for supplying irrigant to the inner lumen of distalportion 82. Deformable polymeric seal 94 closely conforms to instrumentsplaced therethrough so as minimize leakage of fluid from the site.Proximal-most surface 96 of proximal portion 86 has a circular recess 98formed therein so as to form a circumferential rim 100 wherein are aplurality of slots 102, slots 102 being similar in form to slots 28 ofisolator 1 (FIGS. 1 through 3). That is, slots 102 have a narrow distalportion having a width suited to releasably securing therein suturegenerally used for arthroscopic rotator cuff repair, and a taperedproximal portion to aid in positioning the suture within the slot.

Referring to FIG. 17, seal 94 has a plurality of slits 95 forming aplurality of flaps 93, slits 95 terminating in angled slits 97. Duringuse a suture 99 which has been retrieved through cannula 80 ispositioned within a slit 97 and secured in a slot 102 to maintaintension in and orientation of suture 99. When the suture has beensecured, flaps 93 can return to and maintain their closed positions soas to minimize leakage through the seal. This is in contrast to seal 54of cannula 50 (FIGS. 4 through 6) in which a suture passing through theseal and maintained under tension will frequently hold flaps 53 openthereby causing leakage through the seal.

Use of the suture isolator during arthroscopic repair of a rotator cufftear is shown in FIG. 18. Use is illustrated using the embodiment ofFIG. 17, cannula 80 having integral suture retaining slots. Use of theother embodiments, each with the associated cannula, is identical tothat illustrated. Cannula 80 is positioned in a portal so as to functionas the working cannula, used for passing instruments and sutures.Rotator cuff 110 has a tear 112. Trough 114 has been created in humeralhead 116 and an anchor such as the Arthex Corkscrew Suture Anchor™loaded with two sutures 118 and 120 is inserted into humeral head 116 intrough 114. Sutures 118 and 120 slide freely in the eyelet of the anchorand are differently colored to allow easy identification of the leg pairof a given suture. Suture legs 122 and 124 form a pair, and legs 126 and128 form another pair.

In FIG. 18, leg 122 has been retrieved through cannula 80 and removablysecured in slot 130, slight tension being maintained in leg 122. Using asuture passing instrument such as the Arthex Needle Punch™, leg 124 hasbeen passed through cuff 110, retrieved through cannula 80, andremovably secured in slot 132 with slight tension being maintained inleg 124. Insertion of the instrument, passing of the suture, andretrieval of the leg are accomplished without interference from leg 122because leg 122 is colinear with the cannula and the instrument motions,and slight tension is maintained in leg 122. Subsequently, legs 126 and128 will be retrieved in the same manner as legs 122 and 124. Suture 118is then used as a traction suture. The tension in legs 122 and 124 isincreased so as to move the edge of cuff 110 to the insertion point. Thecuff is then secured in place using suture 120 by sliding knots in theusual manner. Tangling during knot tying is prevented by separation ofthe sutures and slight tension maintained in the sutures by the sutureisolator cannula. Suture 118 is then tied in the same manner as suture120.

FIGS. 23, 24 and 25 represent a diagrammatic sequence showing how theinvention can be used to organize sutures and apply tension to therotator cuff edge to accomplish reduction of the rotator cuff edge toits insertion area when doing a multi-anchor repair. FIG. 23demonstrates a top view of the rotator cuff edge 160, the cuff insertionarea 161 and the anticipated anchor insertion points 170 and 171. FIG.24 shows anchors 172 and 173 deployed. Sutures 175, 176, 177 and 178have been passed through the rotator cuff and diagrammatically securedby the invention represented by the solid line 180. FIG. 25 shows therotator cuff edge reduced into its' insertion area by tensioning sutures175, 176, 177 and 178. Each suture pair is locked into the invention180, holding tension on each suture pair, spreading the reduction forceover multiple points. In addition, the patient's arm can be abductedduring this maneuver to bring the insertion area closer to the rotatorcuff edge. The suture pairs can then be tied down and cut, one pair at atime. The untied suture pairs hold the rotator cuff edge reduced,facilitating the knot tying process.

Other configurations are possible in which the positions of the sutureretaining slots are varied. For instance FIGS. 19 and 20 show a cannula140 in which a circumferential rim 142 is added to the proximal end ofthe cannula and a plurality of circumferential slots 144 are formed inthe rim. In another embodiment, cannula 150, shown in FIGS. 21 and 22, aplurality of cylindrical protrusions 152 are formed on thecircumferential surface 158 of the cannula proximal portion 154, withslots 156 formed in the protrusions. In this embodiment suture retrievedthrough the cannula is positioned in the slots in the seal as in cannula80 (FIGS. 14 through 18), is wrapped around a protrusion 152 andpositioned in slot 154. Those of skill in the art will recognize that inall cases where a suture organizer is shown integral to a cannula, itmay alternatively be removably secured thereto, and vice versa.

1. A suture organizer comprising a tubular body having a proximal end, adistal end, and a cylindrical wall extending therebetween that surroundsand encloses a central bore that defines a longitudinal axis, wherein:the distal end of the central bore is provided with a cylindrical recessthat fixedly engages a cylindrical proximal portion of a workingcannula; and the proximal end of the central bore is provided with arigid peripheral rim, said rigid peripheral rim having a plurality ofsuture retaining features for receiving and tensioning sutures duringrotator cuff repair or other arthroscopic procedures disposed about anouter edge thereof.
 2. The suture organizer of claim 1, wherein saidrigid peripheral rim is made of a rigid metallic or polymeric material.3. The suture organizer of claim 1, wherein said rigid peripheral rimextends proximally away from the body, further wherein said plurality ofsuture retaining features comprise a series of slots formed in anexternal surface of said peripheral rim.
 4. The suture organizer ofclaim 3, wherein said slots include a proximal opening that defines acentral axis that is parallel to the central bore axis.
 5. The sutureorganizer of claim 3, wherein said slots comprise a wide proximalopening that tapers to a narrow suture-securing distal portion.
 6. Thesuture organizer of claim 1, wherein said rigid peripheral rim comprisesa circumferential surface extending outwardly away from the body in adirection that is normal to the central bore axis, further wherein saidplurality of suture retaining features comprise a series of slots formedin said circumferential surface.
 7. The suture organizer of claim 1,wherein said plurality of suture retaining features comprise a series ofprotrusions provided on an external surface of said peripheral rimaround which a suture material may be wound, said protrusions extendingoutwardly away from the body in a direction that is normal to thecentral bore axis.
 8. The suture organizer of claim 7, wherein saidprotrusions further comprise cylinders having suture-securing slotsprovided thereon.
 9. The suture organizer of claim 1, further comprisinga deformable polymeric seal disposed in said central bore that minimizesfluid flow therethrough.
 10. The suture organizer of claim 1, whereinseal has a plurality of radial slits that define a plurality of flaps,each of slits provided with an angled terminus through which a suturemay pass.
 11. The suture organizer of claim 1, further including aworking cannula affixed thereto, said working cannula comprising acylindrical proximal portion that engages said cylindrical recess of thedistal end of said body.
 12. A suture organizing system comprising: aworking cannula having an elongated tubular distal portion, acylindrical proximal portion, and a inner lumen extending therethroughto define a longitudinal axis, wherein said cylindrical proximal portionincludes the suture organizer of claim
 1. 13. The suture organizingsystem of claim 12, wherein said plurality of suture retaining featurescomprise a series of slots integral with said exterior surface.
 14. Thesuture organizing system of claim 12, wherein the suture organizer isintegral with said working cannula.
 15. The suture organizing system ofclaim 12, wherein the suture organizer is removably secured to saidworking cannula.
 16. A suture organizing system comprising: a. a workingcannula having an elongated tubular distal portion, a cylindricalproximal portion, and a inner lumen extending therethrough to define alongitudinal axis; and b. a suture organizer comprising a tubular bodyhaving a proximal end, a distal end, and a cylindrical wall extendingtherebetween that surrounds and encloses a central bore that defines alongitudinal axis, wherein: a cylindrical recess at the distal end ofthe central suture organizer is affixed to the cylindrical portion atthe proximal end of the working cannula, such that said inner lumen andcentral bore are collinear and form a continuous fluid passageway, andthe proximal end of said suture organizer is provided with a rigidperipheral rim, said rigid peripheral rim having a plurality of sutureretaining features for receiving and tensioning sutures during rotatorcuff repair or other arthroscopic procedures disposed about an outeredge thereof.
 17. The suture organizing system of claim 16, wherein saidworking cannula further comprises an inflow tube disposed near theproximal end of the distal portion for supplying irrigant to saidcannula inner lumen.
 18. The suture organizing system of claim 16,further comprising a deformable polymeric seal disposed in said fluidpassageway that minimizes fluid flow therethrough.
 19. The sutureorganizer of claim 18, wherein seal has a plurality of radial slits thatdefine a plurality of flaps, each of slits provided with an angledterminus through which a suture may pass.
 20. The suture organizingsystem of claim 18, wherein said deformable polymeric seal is situatedin the inner lumen of said cannula.
 21. The suture organizing system ofclaim 18, wherein said deformable polymeric seal is situated in thecentral bore of said suture organizer.
 22. The suture organizing systemof claim 16, wherein the suture organizer is integral with said workingcannula.
 23. The suture organizing system of claim 16, wherein thesuture organizer is removably secured to said working cannula.
 24. Thesuture organizing system of claim 16, wherein said rigid peripheral rimis made of a rigid metallic or polymeric material.
 25. The sutureorganizing system of claim 16, wherein said rigid peripheral rim extendsproximally away from the body, further wherein said plurality of sutureretaining features comprise a series of slots formed in an externalsurface of said peripheral rim.
 26. The suture organizing system ofclaim 25, wherein said slots include a proximal opening that defines acentral axis that is parallel to the central bore axis.
 27. The sutureorganizing system of claim 25, wherein said slots comprise a wideproximal opening that tapers to a narrow suture-securing distal portion.28. The suture organizing system of claim 16, wherein said rigidperipheral rim comprises a circumferential surface extending outwardlyaway from the body in a direction that is normal to the central boreaxis, further wherein said plurality of suture retaining featurescomprise a series of slots formed in said circumferential surface. 29.The suture organizing system of claim 16, wherein said plurality ofsuture retaining features comprise a series of protrusions provided onan external surface of said peripheral rim around which a suturematerial may be wound, said protrusions extending outwardly away fromthe body in a direction that is normal to the central bore axis.
 30. Thesuture organizing system of claim 29, wherein said protrusions furthercomprise cylinders having suture-securing slots provided thereon.
 31. Amethod for reducing a tear in rotator cuff during arthroscopic surgery,comprising the steps of: i. providing the suture organizing system ofclaim 16; ii. positioning the working cannula in portal to allow for thepassage of instruments and sutures through said working cannula innerlumen; iii. placing an anchor having a set of sutures into a humeralhead, with one of the sutures being passed around a portion of the tear;iv. retrieving the set of sutures through the cannula; v. parking andtensioning the retrieved sutures in the suture retaining features of therigid peripheral rim of the suture organizer; vi. repeating steps iii)through v) as necessary; and vii. securing the cuff in place usingsliding knots on the various sets of sutures.
 32. The method of claim31, wherein the various sets of sutures are color-coded.